Kornimate/medical-research-clean huggingface dataset:
biomarkers of immune-related toxicity

Conditions: Cancer; Metastatic Cancer

Summary: this is a single-center, correlative pilot study evaluating potential biomarkers predictive of immune-related adverse events associated with immune checkpoint inhibitor therapy.

this is a single-center, correlative pilot study evaluating potential biomarkers predictive of immune-related adverse events associated with immune checkpoint inhibitor therapy. the study includes a control population of patients receiving standard chemotherapy as a comparator. patients will undergo blood draws at 4 time-points while on standard of care treatment. there are no study-related medications or interventions beyond blood sampling.

Eligibility criteria:
inclusion criteria: 1. metastatic solid tumor cancer of any primary site, with the exception of lymphoma 2. ≥18 years of age 3. life expectancy \>6 months 4. starting new regimen of ipilimumab, nivolumab, pembrolizumab or atezolizumab as a single agent or in combination according to standard of care or through compassionate use granted by the pharmaceutical company (immune checkpoint inhibitor arm only) or starting new regimen of standard cytotoxic chemotherapy (control arm only) 5. provision to sign and date the consent form 6. stated willingness to comply with all study procedures and be available for the duration of the study exclusion criteria: 1. prior immune checkpoint inhibitor therapy with anti-ctla4, anti-pd1 or anti-pd-l1 targeting agent 2. known autoimmune disease 3. known acute or chronic infection, including viral infections such as hepatitis b, c, and hiv 4. chronic treatment with immune suppressive medications, including steroids, at the time of study enrollment 5. concomitant treatment with a monoclonal antibody in addition to cytotoxic chemotherapy (i.e. bevacizumab, cetuximab, trastuzumab) (control arm only) 6. known pregnancy or lactation

Keywords: immune checkpoint inhibitors biomarkers immune related adverse event
sirolimus-eluting stent calypso vs everolimus-eluting stent xience

Conditions: Ischemic Heart Disease; Coronary Atherosclerosis; Coronary Artery Disease; Coronary Artery Stenosis

Summary: the aim of the study is to evaluate the efficacy and safety of sirolimus-eluting coronary stent "calypso" (angioline, russia) in comparison with everolimus-eluting coronary stent "xience" (abbott vascular, usa)


Eligibility criteria:
inclusion criteria: * patients considered for coronary angioplasty with stenting due to ischemic heart disease (stable angina, unstable angina, non-st myocardial infarction). * target vessel lesion in coronary artery with diameter measurements \>2.5 mm \& \< 4.5 mm. * signed, documented informed consent prior to admission to the study exclusion criteria: * age \ 75 years * renal insufficiency (gfr/mdrd \<30 ml/min) * subject has a platelet count \ 700,000 cells/mm3. * known non-adherence to dapt * lvef \<30% * known oncology * severe cardiac valvular pathology, requiring operative treatment within 1 year * anemia (hb\<100 g/l) * continuing bleeding * acute coronary syndrome (st-elevation myocardial infarction) * anamnesis of previous coronary angioplasty/stenting or cabg * nyha class (dyspnoea) iv or hospitalization during last year due to chronic cardiac failure as a primary diagnosis. * pregnancy * coronary pathology requiring cabg or staged scheduled coronary angioplasty/stenting except cases of unscheduled staged coronary angioplasty/stenting within 4 weeks after primary procedure.

Keywords: calypso xience coronary stenosis drug-eluting stent coronary angioplasty with stenting ischemic heart disease
rehabilitation with or without knee orthosis following meniscal repair

Conditions: Meniscal Tear

Summary: rct to determine if a less restrictive postoperative rehabilitation protocol following meniscal repair results in a faster return to normal knee function without compromising rates of healing.

the purpose of the study is to compare rehabilitation after meniscal repair with or without the use of a knee orthosis. there is conflicting evidence regarding optimal postoperative rehabilitation following meniscal repair with aclr. many surgeons advocate the use of a knee orthosis which restricts flexion during the first 4-6 weeks following surgery. some also avoid weight baring and crouching for various periods of time. this is due to the perceived risk that the healing meniscus is exposed to unnecessary strain, potentially compromising healing. there is however evidence that fewer postoperative restriction in the setting of meniscal repair in conjunction with aclr does not compromise meniscal healing. there is also evidence that accelerated rehabilitation following isolated meniscal repair does not increase the risk of failure. the study design is a prospective randomized study with equal groups. a power analysis has been performed indicating that 57 patients in each group are required to detect a significant difference between groups, as such a cohort of 120 patients will be recruited. randomisation will continue until 60 patients are allocated to both groups. randomization process and study design will be done according to the consort guidelines.

Eligibility criteria:
inclusion criteria: • meniscal tear in the peripheral zone of the meniscus, repaired using at least two sutures. exclusion criteria: * associated injury of the knee requiring surgical or non-surgical intervention that precludes the patient from completing accelerated rehabilitation- fracture, concomitant ligament or cartilage injury. * previous meniscal repair in the affected meniscus * bmi over 30
study of xl999 in patients with metastatic renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: this clinical study is being conducted at multiple sites to determine the activity, safety, and tolerability of xl999 when given weekly to patients with metastatic clear cell renal cell carcinoma (rcc). xl999 is a small molecule inhibitor of multiple kinases including vegfr, pdgfr, fgfr, flt-3, and src, which are involved in tumor cell growth, formation of new blood vessels (angiogenesis), and metastasis.


Eligibility criteria:
inclusion criteria: * males and females with histologically confirmed metastatic clear cell rcc * measurable disease according to response criteria for solid tumors (recist) * no prior systemic cytotoxic chemotherapy * subjects who have received either no prior therapy for rcc, systemic immunotherapy only (such as interleukin-2 or interferon), or one agent targeting vegf or a vegfr (eg, bevacizumab, sorafenib, or sunitinib malate) may be enrolled * ecog performance status of 0 or 1 * life expectancy ≥3 months * adequate organ and marrow function * no other malignancies within 5 years * signed informed consent exclusion criteria: * radiation to ≥25% of bone marrow within 30 days of xl999 treatment * subjects who have received systemic anticancer therapy within 30 days of xl999 treatment * subjects who have not recovered to grade ≤1 or to within 10% of baseline from adverse events due to medications administered \>30 days prior to study enrollment * history of or known brain metastases, current spinal cord compression or carcinomatous meningitis * uncontrolled and/or intercurrent illness * pregnant or breastfeeding females * known hiv

Keywords: kidney cancer metastatic
patients with pulmonary hypertension or interstitial lung disease at altitude - effect of oxygen on breathing and sleep

Conditions: Precapillary Pulmonary Hypertension; Interstitial Lung Disease

Summary: the purpose of this study is to investigate the effect of travelling to moderate altitude and of nocturnal oxygen therapy during a stay at moderate altitude on breathing and sleep of patients with pulmonary hypertension or with interstitial lung disease.

patients with pulmonary hypertension or with interstitial lung disease living below 800 m will be invited to participate in a randomized, cross-over field trial evaluating the hypotheses that: a), breathing and sleep during a 2 day sojourn at moderate altitude are impaired in comparison to low altitude; b), breathing and sleep during a 2 day sojourn at moderate altitude are improved by nocturnal oxygen therapy compared to room air (sham oxygen) administered during nights at altitude. outcomes will be assessed at low altitude (zurich, 490 m, baseline), and during 2 study periods of 2 days each spent at moderate altitude (st. moritz salastrains, 2048 m), separated by a wash-out period of at least 2 weeks spent at low altitude (\<800 m). the order of stays at the different altitudes and of the treatments will be randomized.

Eligibility criteria:
inclusion criteria: * precapillary pulmonary hypertension, or interstitial lung disease. * new york heart association class 2-3. * residence at low altitude (\<800m). exclusion criteria: * unstable or exacerbated condition * very severe pulmonary hypertension or interstitial lung disease, new york heart association class 4 * requirement for oxygen therapy at low altitude residence * hypoventilation * more than mild or unstable cardiovascular disease * use of drugs that affect respiratory center drive * internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day), inability to perform 6 min walk test. * previous intolerance to moderate altitude (\<2600m). * exposure to altitudes \>1500m for \>2 days within the last 4 weeks before the study. * pregnant or nursing patients

Keywords: pulmonary hypertension interstitial lung disease pulmonary fibrosis
ultrasound-guided lumbar erector spinae plane block versus caudal block for postoperative analgesia in hip and proximal femur surgery in pediatric patients

Conditions: Post Operative Pain

Summary: the study will compare ultrasound-guided lumbar erector spinae plane block and caudal block for postoperative analgesia in hip and proximal femur surgery in pediatric patients


Eligibility criteria:
inclusion criteria: * asa i-ii. * scheduled to undergo hip or proximal femur surgeries. exclusion criteria: * refusal of participation by parents or caregivers * known local anesthetic (la) drug sensitivity * bleeding disorders with inr \> 1.5 and/or platelets \< 100,000/mm3. * skin lesions or wounds at the site of proposed needle insertion.
comparison of temperature using tracheal thermometer and pulmonary artery catheter in adult patients undergoing cabg

Conditions: Coronary Artery Disease

Summary: in anesthesia, monitoring of core body temperature is one of important factors. measurement of temperature using a pulmonary artery catheter is representative one of core temperature measurements. the core temperature by a pulmonary artery catheter is compared with the tracheal temperature by an endotracheal tube with thermometer. this study was designed to confirm the accuracy of the endotracheal tube thermometer.

all patients undergoing general anesthesia are monitored core body temperature. coronary artery bypass graft surgery needs general anesthesia with endotracheal intubation and insertion of pulmonary artery catheter. using endotracheal tube with thermometer and pulmonary artery catheter, the investigators will measure tracheal temperature and pulmonary artery temperature every 5 minutes for 1 hour after induction of general anesthesia. standard monitoring devices (non-invasive bp, electrocardiogram, pulse oxygen saturation) are applied to participants in an operation room, and 1% propofol 1-2 mg/kg and rocuronium 0.8 mg/kg are administered intravenously for induction of general anesthesia. an endotracheal tube with thermometer (human endotracheal tube, insung medical co., korea) is inserted. after inserting a 9fr central venous catheter with a pulmonary artery catheter insertion port, core body temperature is measured by a pulmonary artery catheter (swan-ganz ccombo v, edwards lifesciences, irvine, california, usa). tracheal temperature will be compared with pulmonary artery temperature by using bland-altman method.

Eligibility criteria:
inclusion criteria: * adult patients over 18-year-old undergoing coronary artery bypass surgery exclusion criteria: * emergency surgery
impact of health literacy on chronic non-specific low back pain

Conditions: Low Back Pain

Summary: this prospective cohort study aims to assess the impact of health literacy on the quality of life in patients with chronic non-specific low back pain.

this prospective cohort study will enroll patients with chronic non-specific low back pain. patients will be assessed using turkey health literacy scale-32, short form-36 health survey, and oswestry disability index. the correlation between health literacy and quality of life will be assessed with statistical tests.

Eligibility criteria:
inclusion criteria: -chronic non-specific low back pain exclusion criteria: * acute low back pain * radicular pain * spinal stenosis
how simplified language affects comprehension and learning in young children with down syndrome

Conditions: Down Syndrome

Summary: the long-term study goal is to experimentally evaluate the components (and likely active ingredients) of early language interventions for young children with down syndrome (ds). the overall objective is to determine how single-word and telegraphic simplification affects real-time language processing and word learning in young children with ds (relative to full, grammatical utterances). the proposed project will investigate three specific aims: 1) determine how single-word and telegraphic simplification affects language processing. 2) determine how single-word and telegraphic simplification affects word learning. 3) evaluate child characteristics that may moderate the effects of linguistic simplification on language processing and word learning. aim 1 will test the hypothesis that children with ds will process grammatical utterances faster and more accurately than telegraphic or single-word utterances. aim 2 will test the hypothesis that overall, children will demonstrate better word learning in the grammatical compared to the single-word and telegraphic conditions. aim 3 will test the hypothesis that receptive language and nonverbal cognitive abilities will be significant moderators, such that children with stronger linguistic and cognitive skills will show the greatest benefit from grammatical input but children with lower linguistic and cognitive scores will perform similarly across conditions.


Eligibility criteria:
inclusion criteria: * down syndrome english as primary language 2-7 years old exclusion criteria: * acquired brain injury cerebral palsy uncorrected vision or hearing impairment

Keywords: down syndrome language development language processing language input
measuring depth of unconsciousness at the end of life using bispectral index (bis)

Conditions: Loss of Consciousness at End of Life

Summary: the purpose of this study is to use the bis monitor to assess the degree of consciousness in pre-terminal palliative patients admitted to our palliative care unit and to ascertain if this tool provides a more accurate assessment of consciousness in this specific group of patients than clinical observation of consciousness and the use of sedation scales. we hypothesize that the measured bis results provide a more accurate assessment of the patient's level of consciousness than routine clinical observation or the use of sedation scales.


Eligibility criteria:
inclusion criteria: * pre-terminal palliative patients with a life expectancy of 72 hours or less at the start of the observation. exclusion criteria: * lack of consent of patient or representative
[18f]fes pet/ct in endocrine refractory breast cancer

Conditions: Estrogen Receptor Positive Breast Cancer; Breast Neoplasm; Metastatic Breast Cancer

Summary: in this study, positron emission tomography (pet/ct) imaging will be used to evaluate estrogen receptor (er) activity in sites of metastatic disease using the investigational radiotracer \[18f\]fluoroestradiol (fes).

this study will evaluate \[18f\]fes pet/ct uptake as a predictor of progression free survival in endocrine refractory recurrent or metastatic breast cancer patients starting a new therapy regimen including endocrine targeted therapy. imaging will occur prior to starting new therapy. some patients may also undergo a second fes pet/ct scan at the time of suspected progression of disease to compare for changes in fes uptake measures. this is an observational study in that \[18f\]fes pet/ct will not be used to direct therapy decisions.

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age 2. recurrent or metastatic cancer that is of known or suspected breast origin - may be biopsy proven or identified on standard imaging (e.g. ct, bone scan, mri, fdg pet/ct) 3. history of er+ pathology (er+ may be confirmed from surgery or biopsy of primary breast cancer or lymph nodes, and/or surgery or biopsy of a metastatic site, metastatic biopsy is not required) 4. at least one site of disease outside of the liver that is seen on standard imaging (e.g. ct, bone scan, mri, fdg pet/ct); patients with measurable or nonmeasurable disease are allowed. 5. history of progression or recurrence of disease while on an endocrine targeted therapy containing regimen as assessed by medical record review of breast cancer history at screening 6. participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures exclusion criteria: 1. females who are pregnant at the time of screening will not be eligible for this study, urine pregnancy test will be performed at screening in women of child-bearing potential. 2. inability to tolerate imaging procedures in the opinion of an investigator or treating physician 3. serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study. 4. history of her2/neu positive cancer (ihc 3+ and/or fish positive) as assessed by medical record review at screening
risk factors for hearing loss as a result of exposure to noise during military training in the idf

Conditions: Hearing Loss, Noise-Induced

Summary: as part of the proposed work, the investigators would like to examine whether there is a need to use a training video to train idf combat soldiers to improve the use of ear plugs and to prevent hearing loss from exposure to noise, and to characterize the hearing impaired epidemiology of recruits and the basic rate of hearing loss during basic training.

1. auditory screening examination using an oae (oto acoustic emission) device during the first week of training in the unit and before starting to be exposed to noise . 2. if the indication obtained by the oae device is negative, the soldier will be transferred to perform an audiometer test by a medic. 3. if the audiometer is subjected to a significant drop (over 25 decibels), the soldier will be referred to an audiologic examination that includes a comprehensive hearing test and an examination by the ent (ear, nose and throat). 4. all participants will be randomly assigned to two groups after signing an agreement form: a - the video group - will be guided by a screening of a 7 minute video that explains the importance of using ear plugs and correct installation. b- the control group, will be instructed to use earplugs properly, including practical exercises by a medic. 5. after two months of training, all participants will undergo further instruction in the use of earplugs, the video clip group and the control group trained by a medic only, 6. towards the end of the training after six months of the recruitment, the investigators will perform an additional hearing test for all the participants in order to compare the results to the examination performed near their recruitment. similar to the first stage, the test will be performed using an oae device. 7. a comparison shall be made in the auditory results data between the group that underwent training via video and the control group.

Eligibility criteria:
inclusion criteria: * soldiers who joined the idf from august 2018 exclusion criteria: * lack of informed consent. * recruits who have auditory impairment that is disqualified from fighting

Keywords: hearing loss during basic training, otoacoustic emission
comparing diuretic strategies in hospitalized heart failure

Conditions: Heart Failure

Summary: we will conduct a pragmatic randomized trial comparing whether using a combination of two types of diuretics (loop + thiazide) compared with using a single diuretic (loop only) will result in shorter hospital stays for patients hospitalized with heart failure.


Eligibility criteria:
inclusion criteria: any adult (age ≥18 years) admitted to the heart failure service at stanford health care with an indication for treatment with a diuretic. exclusion criteria: 1. admission to the intensive care unit or cardiac care units 2. maintenance dialysis on admission 3. any mechanical circulatory support on admission 4. history of heart transplant 5. allergy / intolerance to loop or thiazide diuretics 6. admission serum sodium \< 125 meq/l (from epic) 7. admission serum potassium \< 3.0 meq/l (from epic)

Keywords: diuretics
topical rosemary oil application in systemic sclerosis

Conditions: Systemic Sclerosis

Summary: the objectives of this prospective crossover, open-label, nonrandomized study are to estimate effect sizes of vasodilatation and sense of warmth after application of topical rosemary essential oil in patients suffering from systemic sclerosis.

in a crossover design, patients suffering from systemic sclerosis (12 subjects) receive applications of olive oil and of 10% rosmarinus officinalis l. (rosemary) essential oil to both hands with a wash-out period of 3 hours. effects on vasodilatation are measured with infrared thermography. patients' sense of warmth is assessed by the "herdecke warmth perception questionnaire". measurements take place at baseline and 45 minutes following the interventions (pre-post-comparison). to determine within and between-differences, 2-sample t-tests will be used and effect sizes will be calculated (standardized effect size).

Eligibility criteria:
inclusion criteria: * systemic sclerosis with skin involvement of hands and fingers * raynaud phenomenon with frequent symptoms of cold hands exclusion criteria: * topical treatment with nitroglyceride * lymphdrainage \< 24 hours * other topical treatment of hands and arms \< 4 hours prior to study intervention